Flexible storage container

ABSTRACT

A flexible container for fluid administration is provided having a body defining a cavity, a base, and at least one port comprising a flange in contact with a flange of a terminal port having a punctureable membrane layer. The body has a cross-sectional configuration including a lower body section of a first dimension, a middle body section of a second dimension, and an upper body section of a third dimension, wherein the second dimension is smaller than the first dimension and the third dimension. The flexible container may also include a base having a plurality of creases that are foldable to form two folded ends each including an extension having a base of a first dimension and a tip of a second dimension.

CROSS-REFERENCE TO RELATED APPLICATION

This is a regular application of provisional application Ser. No.60/953,153, entitled Flexible Container, filed Jul. 31, 2007, thecontents of which are expressly incorporated herein by reference.

FIELD OF ART

A molded container for fluid administration and infusion is generallydiscussed herein with specific disclosure directed to gravity feedcollapsible molded container having a base adapted to stand on its endor hung from a dispensing pole.

BACKGROUND

Containers for dispensing fluids come in many shapes, types and sizes. Atypical container includes a vial or a container body, a cap, and a sealfor sealing the interface therebetween. The cap may be removable fordispensing the stored fluid or alternatively a separate channel, port,or weakened section provided for dispensing the stored fluid.

For a nutritional or therapeutic container designed for intravenous use,the container further includes means for port access. e.g. formedication additions or withdrawals to the container. This typicallyinvolves use of a rubber septum to be punctured by a needle withsyringe. Also for drainage, an IV spike access port is present. Priorart filled infusion containers (particularly flexible PVC IV bags) areoften laid on their sides during use due to their design, which makesprepping them for use, such as removing the cap or swabbing the ports,somewhat inconvenient.

Most prior art blow molded containers are also designed with a fixedvolumetric storage capacity. Thus, it is often difficult to add asupplement or an additive to the prior art containers. Draining suchcontainer can also be difficult if the container does not collapse orcollapse in a predictable fashion.

Accordingly, there is a need for a port access type container that iseasy to make, fill, and seal with low residual air volume that cansubstantially be drained of fluid without the need for an externalpressure applied to the container. There is also a need for a containerwhich can stand on its own to facilitate prepping and one that readilyaccommodates a supplement or an additive.

SUMMARY

A flexible container for fluid administration is provided capable ofhanging on a pole or standing upright on a support. The containercomprises a body defining a cavity a base, and at least one portcomprising a flange in contact with a flange of a terminal port. Thebody comprises a cross-sectional configuration comprising a lower bodysection of a first dimension, a middle body section of a seconddimension and an upper body section of a third dimension. In certainaspects of the present invention the second dimension is smaller thanthe first dimension and the third dimension. The base may include tourcorners generally located on a plane for standing the container uprighton a support.

A method for using a flexible container for fluid administration is alsoprovided including filling a container comprising a body defining acavity with a first fluid to a first selected volume. The body has across-sectional configuration including a lower body section of a firstdimension, a middle body section of a second dimension, and an upperbody section of a third dimension, wherein the second dimension issmaller than the first dimension and the third dimension. The methodfurther includes enclosing a port in fluid communication with the cavityadding a second fluid through the port to a second selected volume, andexpanding the second dimension a greater amount than the first dimensionand the third dimension.

Further provided is a flexible container for fluid administrationcapable of hanging on a pole or standing upright on a support comprisinga body defining a cavity, a base having a hanging tab having an opening,and at least one port comprising a flange in contact with a flange of aterminal port. The base can include a plurality of creases that arefoldable to form two folded ends each comprising an extension havingopposing exterior surfaces and comprising a base of a first dimensionand a tip of a second dimension.

A method for using a flexible container for fluid administration isprovided including filling a container including a base having a hangingtab having an opening and at least one port with a fluid to a firstvolume, wherein the base has a plurality creases. The method furtherincludes folding the plurality of creases to form at least one extensioncomprising a base of a first dimension and a tip of a second dimensionand standing the container on its base.

Further provided is a flexible container for fluid administration havinga body defining a cavity, a base having a hanging tab having an opening,and at least one port comprising a flange in contact with a flange of aterminal port comprising a puncturable membrane layer. The terminal portincludes one of a groove and a lip matable with a spike having the otherof the groove and the lip. The lip and the groove are located such thatwhen the lip is mated with the groove, the spike is sufficiently locatedwithin the terminal port to provide fluid to the flexible container.

In its broadest scope, a flexible container provided in accordance withaspects of the present invention comprises a body section defining aninterior cavity, a base extending on an end of the body opposite adischarge end, and a port comprising at least one of a cap or a peelableseal.

Another aspect of the present invention is a container comprising a bodysection, a base, and a nozzle section comprising at least one nozzleattached to a terminal port comprising a housing having a stopperpositioned therein; said stopper comprising an outer wall, a centralwall, and a gap therebetween; said gap being occupied by a plurality ofspaced-apart ribs, each of said plurality of spaced-apart ribs being incontact with both the outer wall and the central wall.

In a further aspect of the present invention, the stopper is made from aself-lubricating silicone material. Alternatively, the stopper is madefrom polyisoprene material.

In certain embodiments, the self-lubricating silicone material isimpregnated with antimicrobial metals.

A method for making a blow-molded container, said method comprising:blowing hot parison against a mold to create an interior cavity forstoring fluid and a nozzle end comprising at least one nozzle; removingthe container from the mold; said container comprising a plurality ofedges connected to a container front wall surface and a container rearwall surface; and reducing a depth profile of the container along theplurality of edges while the container is warmer than ambienttemperature.

In certain embodiments, the depth profile of the container along theplurality of edges is reduced using a vacuum source.

In certain other embodiments, the depth profile of the container alongthe three edges is reduced using a mechanical source which in apreferred embodiment comprises two opposing clamps.

These and other features of the present invention will be betterunderstood upon review of the drawings and written description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded view of a flexible container having a nozzleassembly according to aspects of the present invention.

FIG. 2 is a detail view of a nozzle assembly according to aspects of thepresent invention.

FIGS. 3 a and 3 b are a top view and a cross-sectional viewrespectively, of an upper add port according to aspects of the presentinvention.

FIG. 4 is a cross-sectional view of a cap according to aspects of thepresent invention

FIGS. 5 a and 5 b are a cross-sectional view and a perspective view,respectively of a septum according to aspects of the present invention.

FIG. 6 is a cross-sectional view of an alternate embodiment of a septumaccording to aspects of the present invention.

FIG. 7 is a cross-sectional view of a set port according to aspects ofthe present invention.

FIGS. 8 a and 8 b are a side view and a detail view, respectively, of aspike having a groove according to aspects of the present invention.

FIG. 9 is a detail view of a spike having a lip and a set port having agroove according to aspects of the present invention.

FIG. 10 is a side view of an exemplary container having an hourglassshape according to aspects of the present invention.

FIG. 11 is a side view of another exemplary container having anhourglass shape according to aspects of the present invention.

FIG. 11 is a side view of vet another exemplary container having anhourglass shape according to aspects of the present invention.

FIGS. 13 a and 13 b are a side view and a top view of a flexiblecontainer having a foldable base according to aspects of the presentinvention.

FIG. 13 c is a perspective detail view of a foldable base in a collapsedposition according to aspects of the present invention.

FIG. 13 d is a schematic perspective view of a foldable base in atransition position according to aspects of the present invention.

FIGS. 14 a and 14 b are a side view and a top view of another flexiblecontainer having a foldable base according to aspects of the presentinvention.

FIG. 14 c is a perspective detail view of another foldable base in acollapsed position according to aspects of the present invention.

FIG. 15 is a schematic front view of a container provided in accordancewith aspects of the present invention.

FIG. 16 is a schematic front view of an alternative container providedin accordance with aspects of the present invention.

FIG. 17 is a perspective view of the container of FIG. 15 or 16.

FIG. 18 is a side view of the container of FIG. 17.

FIG. 19 is a perspective view of the container of FIG. 17 interposedbetween two clamps, which in the embodiment shown are U-shaped inconfiguration.

FIG. 20 is a side view of the assembly of FIG. 19.

FIG. 21 is a front view of the assembly of FIG. 19.

FIG. 22 is a perspective view of a container that has been compressed bythe clamps of FIG. 19 or a container that has flattened by evacuatingthe air or gas from the container using a vacuum source.

FIG. 23 is a side view of the container of FIG. 22.

FIG. 24 is a schematic depiction of a cross-sectional end view of acontainer of the present invention showing a generally ellipticalconfiguration following blow molding.

FIG. 25 is a schematic depiction of a cross-sectional end view of thecontainer of FIG. 24 being expanded, such as by over-filling thecontainer of FIG. 24 so that its body section expands to store a greatervolume than the original volume.

FIG. 26 is an enlarged perspective view of a nozzle section of acontainer of the present invention that includes a stepped feature.

FIG. 27 is a cross-sectional perspective view of a container provided inaccordance with aspects of the present invention having a set port andan additive port attached to the two container nozzles.

FIG. 28 is a blow up view of the set port of FIG. 27.

FIG. 29 is a blow up view of the set port of FIG. 27 having an IV spikeinserted through the stopper.

FIG. 30 is a top view of a stopper provided in accordance with aspectsof the present invention.

FIG. 31 is a perspective view of the stopper of FIG. 30.

FIG. 32 is a bottom or reversed view of the stopper of FIG. 30.

DETAILED DESCRIPTION

The detailed description set forth below in connection with the appendeddrawings is intended as a description of the presently preferredembodiments of storage containers provided in accordance with aspects ofthe present invention and is not intended to represent the only forms inwhich the present invention may be constructed or utilized. Thedescription sets forth the features and the steps for constructing andusing the storage containers of the present invention in connection withthe illustrated embodiments. It is to be understood, however, that thesame or equivalent functions and structures may be accomplished bydifferent embodiments that are also intended to be encompassed withinthe spirit and scope of the invention. Also, as denoted elsewhereherein, like element numbers are intended to indicate like or similarelements or features.

Referring now to FIG. 1, a storage container 10 is provided inaccordance with aspects of the present invention. In one exemplaryembodiment, the storage container 10 includes a container body 12defining a volumetric storage space, and a first nozzle or port 14 and asecond nozzle or port 16 located at a nozzle or port end 26 of thecontainer body. For simplicity, the container body 12 may be referred toherein as a bag, holding means, or vial, which represents the containerbody shown and more generally any volumetric storage space. In exemplaryembodiments, the vial 12 may be dimensioned to hold about 100 mL, 150mL, or 250 mL of fluid. However, the specific amount of fluid the vial12 is designed to hold is not limited thereto and can vary at thediscretion of the designer. Additionally the vial 12 may have variousgeometries, as described in more detail below.

In one exemplary embodiment, the vial 12 includes a base 22 having ahanging tab 18 with an opening 20. The hanging tab 18 may be pivotablyattached to the base 22 such that the tab is foldable at least about 180degrees around the base. The hanging tab 18 may be constructed tosecurely support a full storage container 10 on a hook or other hangingdevice. In one embodiment, the hanging tab 18 is integrally formed withthe container body 12.

The vial 12 may be formed from a blow molding process, which is wellknown in the art. More particularly, a body section 24, the base 22 thehanging tab 18, and the discharge end 26, which in one embodimentcomprises a first nozzle 14 and a second nozzle 16, are first formedfrom hot parison. The formed body section 24 is then transported to afilling station to be filled with a fluid, such as an infusion liquid,fluid therapy drug delivery, parenteral nutrition, or other desiredfluids, and then to a capping station. In one exemplary embodiment andas further discussed below, two upper port sections 32 and 34 arepressed into mechanical engagement with the two nozzles 14, 16 and thensubsequently secured using a process known as injection attachment. Thisprocess permits filling the container with a minimum of residual air,less than about 20 cc/liter as compared to 50-100 cc/liter for typicalcontainers. The vial 12 may be made from one of several of thermoplasticmaterials, for example, low density polyethylene (LDPE), high densitypolyethylene (HDPE), polypropylene, and nylon or combinations thereof insingle layer or multi-layer wall structures. Exemplary multi-layer wallstructures are disclosed in co-pending application Ser. No. 10/571,985,entitled A CONTAINER FOR INFUSION LIQUIDS, filed Mar. 14, 2006, thecontents of which are expressly incorporated herein by reference.Although vent ports may be incorporated, the vial 12 is pliable andcollapsible uniformly to allow fluids to drain without vent ports. Tofacilitate draining and collapsing, the base and side walls of the vial12 incorporate fold lines in the manner and fashion disclosed in the'985 application.

In one exemplary embodiment, the nozzles 14, 16 may be adapted to serveas additive ports, which permit the addition of fluid and othersubstances into the vial 12, and/or administrative ports, which permitfluid to be drawn from the vial. The nozzles 14, 16 are generallytubular and incorporate a flange or shoulder 30 for mating with terminalports, for example, an upper add port 34 and, or a set port 32 to adaptthe nozzles to become additive ports and/or administrative ports.However, the nozzles 14, 16, as well as the body section 24, may alsohave different geometries, including different sizes, differentcross-sectional shapes, different lengths, and different spacing betweenthe nozzles 14, 16, without deviating from the spirit and scope of thepresent invention. More preferably, the nozzles are sized anddimensioned to accept ports 30, 32, which are configured to fit standardIV sets. With reference also to FIG. 2, in one exemplary embodiment thefirst nozzle 14 is adapted to be an additive port and the second nozzle16 is adapted to be an administrative port.

With reference also now to FIGS. 3 a and 3 b, in one exemplaryembodiment, the upper add port 34 incorporates a sleeve 42, a taperedflange 38 configured to mate with the flange 30 on the nozzle 14, and anotch 40 adapted to receive a lip 48 located on a cap 28 (FIG. 4), asdescribed in more detail below. The sleeve 42 extends from the taperedflange 38 and forms an interference fit with the nozzle 14 totemporarily secure the upper add port 34 until the flanges 30, 38 aresecured together, as described in more detail below. The upper add port34 is inserted into the nozzle 14 until the tapered flange 38 on theupper add port abuts the flange 30 on the nozzle 14. A distal surface 45of the upper add port 34 includes a pierceable membrane 44 and a groove46. In one exemplary embodiment, the distal surface is designed toaccommodate a septum 58 (FIG. 1), which has corresponding features formating with the groove 46. A needle or other sampling means may beinserted into the nozzle 14, through the septum and the membrane,without fluid leaking through the cap. In one exemplary embodiment, theupper add port 34 is made from polypropylene, but other polymericmaterials such as HDPE and LDPE may also be used.

With reference now also to FIGS. 2 and 4, the cap 28 is insertable(snaps) over the upper add port 14 so that the lip 48 on the cap mateswith the notch 40 on the upper add port. A receiving section 5) (FIG. 4)for accommodating a septum 58 is formed between the distal surface 45 ofthe upper add port 34 and an interior surface 53 of the cap. Theinterior surface 53 of the cap may further include an annular septumgroove 50 or multiple groove sections to provide intertwined engagementsurfaces with a septum 58, as described in more detail below. The cap 28may be made from standard prior art molding techniques, such asinjection molding, using a thermoplastic material, such as apolypropylene (PP) material.

An exterior end surface 55 of the cap 28 (FIG. 4) is adapted to receivea peelable cover 72. The peelable cover 72 is configured to providesterility and may be removably sealed to the exterior end surface 55.The peelable cover 72 may be peelable from the exterior end surface 55prior to use and may include a pull tab 73 to facilitate gripping. Thepeelable cover 72 may be heat bonded to the exterior end surface 55 andmay include a polymeric material or a multi-laminate layer that includesan aluminum foil layer.

With reference now to FIG. 5, the septum 58 is configured to maintain afluid tight seal even after a needle or other insertion means has beeninserted into and subsequently withdrawn from the additive port. In oneexemplary embodiment, the cap 28 is placed over the port 34 and theseptum 58 is molded directly into the receiving section 52 of the cap 28by injection molding. However, the septum 58 may also be made separatelyfrom a thermal set material and subsequently placed within the receivingsection 52 of the cap 28. The cap and the septum are then snapped overthe port into engagement with the port. The septum 58 may have ridges 50on opposite surfaces 51 for mating with the septum grooves 46, 50located in the upper add port 34 and the cap 28, respectively to preventlateral movement of the septum 58. In one exemplary embodiment theseptum 58 may include a convex center portion 60 to minimize touchcontamination. In an alternative embodiment, a septum 59 may have aconcave center portion 61 (FIG. 6) to maximize the interference surfacearea. The septum 58, 59 provided in accordance with aspects of thepresent invention may be made from a thermoplastic elastomer material,such as KRATON®, ethylene-propylene diene monomer (EPDM), SANOPRENE™ andPEBAX™ or alternatively from a thermoset elastomer, such aspolyisoprene.

With reference again to FIG. 2, the flange 38 of the upper add port 34abuts the flange 30 of the nozzle 14. In practice, a mold is first usedto clamp the two flanges 30, 38 together and then molten polymericmaterial is injected into the cavity of the mold to form a ring forbonding the two flanges together in a process known as injectionattachment. Further discussion regarding injection attachment isdiscussed in Ser. No. 60/912,881, filed Apr. 19, 2007, entitled STORAGECONTAINER, the contents of which are expressly incorporated herein byreference. The resultant ring is shown as a welded flange 56 in FIG. 2.In one exemplary embodiment, molten polypropylene (PP) material is usedto fuse the two flanges 30, 38 together. However. HDPE LDPE, or otherpolymeric material may also be used. While the welded flange 56 is shownwith stepped surfaces, any configuration, contours, or shape may be usedwithout deviating from the spirit and scope of the present invention. Inyet another alternative embodiment, a different color dye may be usedfor each of the two resultant rings to provide a user with colordifferentiations between the two ports to represent two different porttypes.

With reference now to FIGS. 2 and 7, a set port 32 is provided to beattached to the nozzle 16 to serve as an administrative port. The setport 32 includes a sleeve 68 insertable into the nozzle 16 and a taperedflange 66 for mating contact with the flange 30 on the nozzle 16. Theset port 321 further includes an end flange 70, which provides a surfaceto which the peelable cover 72 (FIG. 2) is removably attached, asdescribed above. Similar to the previously described fabrication stepsan injection attachment process may be used to create a welded flange 56(FIG. 2) to fuse the two flanges 66, 30 of the set port 32 and thenozzle 16, respectively. The set port includes a pierceable membrane 71through which a spike 74 (FIG. 8) may be inserted to allow fluid to bedrained from the vial 12 through the administrative port.

With reference now to FIGS. 7-8 b, in one exemplary embodiment, afeedback mechanism is incorporated to provide visual audible, and/orphysical feedback when a spike 74 positively engages an administrativeport. More specifically in one exemplary embodiment the set port 32includes a lip or ring 76 located adjacent the pierceable membrane 71.The spike 74 is provided with a corresponding mating groove 78 adaptedto mate with the lip or ring 76 on the set port 32. Accordingly, whenthe spike 74 is inserted into the set port 32 through the pierceablemembrane 71 the groove 78 of the spike encounters the lip 76 of the setport and produces an audible click and/or a tactile vibration.Therefore, feedback is provided when the spike 74 has been sufficientlyinserted into the port. In an alternate embodiment as shown in FIG. 9the set port 32 may incorporate a groove 80 and the spike 74incorporates a lip or projection 82. Although a feedback systeminvolving a combination of grooves and lips is shown and described, oneof ordinary skill in the art will appreciate that other feedbacksystems, such as detents, ball bearings and springs, may be used aswell.

With reference now to FIGS. 10-12, various alternate exemplaryembodiments of vials are shown. As noted above, the vials are formedusing a blow molded process in which the body section the base thenozzles and the hanging tab are formed from hot parison are inflatedusing a blowing mandrel or a needle to a certain shaped defined by amold, and allowed to cool to take the shape of the mold.

As shown in FIGS. 10-12, the exemplary vials of the present inventionhave a generally hourglass longitudinal cross-section. The hourglassconfiguration allows a user to add a supplement or an additive into thecontainer by expanding the concave sections of the hourglass body. Inone exemplary embodiment, an additional 1%-35% of the originalvolumetric capacity may be added. In another embodiment, by varying thebase dimension and the amount of concavity of the midsection of thehourglass configuration, 1%-100% of the original volumetric capacity maybe added. Other range of expansion is also contemplated by varying therelative dimensions of the hourglass configuration. To facilitateexpansion and subsequent collapse of the container, the container wallthickness is preferably in the range of about 0.008-0.016 inch. As withthe container disclosed with reference to FIG. 1, fold lines may beincorporated in the base and side walls to facilitate collapsing, as aredisclosed in co-pending application Ser. No. 10/571,985, which haspreviously been incorporated by reference.

With specific reference now to FIG. 10, an hourglass-shaped container100 is shown having a vial or body section 102, a pair of nozzles 104extending from the vial, and a hanging tab 106 integral with a base 108,which has a base having four standing corners for standing the containerupright on its base. Thus, the container may be hung from its tab 106 orstand upright on its base 108. For purposes of illustration, the vial102 may be divided into three sections: An upper body or head section112 adjacent the nozzle 104, a middle body or midsection 114, and alower body or tail section 116 ad adjacent the base 108. As shown inFIG. 10 and as a non-limiting example, the midsection 114 has a widthdimension smaller than the width dimension of the head section 112 andthe tail section 116. In one exemplary embodiment, the length of thebody section excluding the nozzles and the hanging tab is about 9.95inches and a maximum width measured orthogonal to the hourglasscross-section of about 3.49 inches. A maximum width dimension of thevial 102 along the hourglass cross-section is about 1.5 inches measuredat the tail section 116. From the widest width dimension along thehourglass configuration, the midsection 114 tapers to a narrowest pointof about 0.68 inch before widening again to a width of about 1.25inches. Additionally and as previously discussed, when the vial 102 isfilled with fluid, the additional surface area of the concave walls ofthe midsection 114 are expandable to form a generally flat constantcross-section or even a convex shape, therefore providing an additionalvolumetric capacity greater than a comparable container with walls thatare only expandable to be substantially parallel to each other. In onespecific example, an empty volume of the container 100 is about 100 mLwithout expanding the concave walls and expandable to an expanded volumeof about 190 mL when the concave walls of the hourglass configurationare expanded. In operation, as fluid drains from the vial 102, the wallsof the emptying container will return to their empty hourglass shape andeven collapses to the point where the containers interior wall surfacestouch one another to expel substantially all of the fluid contained inthe vial without the need for an external pressure source.

With reference now to FIGS. 11 and 12 the hourglass shape may also bemore defined or less defined. In one exemplary embodiment of a container120 (FIG. 1), a length of the vial 122 is about 5.65 inches and amaximum width of the vial is about 3.69 inches, measured along the planeorthogonal to the hourglass configuration. A maximum thickness or widthdimension along the hourglass cross-section of the vial 122 is about 1.8inches, which tapers to a minimum thickness of about 1.2 inches beforetapering back to a thickness of about 1.5 inches. The empty volume ofthe container 120 is about 250 mL and the full volume of the containeris about 492 mL when filled to expand the concave walls. However, othervolumetric capacities are contemplated by varying the various dimensionsof the container.

With reference now to FIG. 12, in another exemplary embodiment of acontainer 130, a length of the vial 132 is about 3.58 inches and amaximum width of the vial is about 3.49 inches. A maximum thickness ordimension along the hourglass configuration of the vial 132 is about 1.5inches, which tapers to a minimum thickness of about 0.88 inches nearthe concave section before tapering back to a thickness of about 1.1inches. The empty volume of the container 120 is about 70 mL and thefull volume of the container is about 140 mL, when filled to expand theconcave walls. However, other volumetric capacities are contemplated byvarying the various dimensions of the container.

With reference now to FIGS. 13 a-13 d, a container 140 incorporating abody 142 defining a cavity for containing fluid, similar to the vial 12described above, and a base 144 on which the container 140 is adapted tostand is shown. A hanging tab 158 may be integrally attached to the base144, the hanging tab 158 including an opening 160 to allow the container140 to be hung from a hook or other hanging devices. The container 140further includes a port 146 having a flange 148 at a distal end. Theflange 148 is mate-able with a flange of a terminal port, such as theupper add port 34 or set port 39, as described above. In a preferredembodiment, the container incorporates two ports 146, an additive portand an administration port.

In one exemplary embodiment, the body 142 includes an integralmidsection 154 and a tapered tail section 156. The base 144 is integralwith the tapered tail section 156 and the base can be folded along aplurality of creases, against the tapered tail section to act as a standfor the container 140. In one exemplary embodiment, an integral basecrease 145 extends laterally across the body 142 to define a boundarybetween the tapered tail section 156 and the base 144. The base 144 isfurther creased such that the base can be transferred between anexpanded position (FIG. 13 b), which allows the container to be hungfrom the hanging tab 158, and a collapsed position (FIG. 13 c), whichallows the container to stand upright on the base. More specifically,the base 144 includes a plurality of first creases 152 a plurality ofsecond creases 1537 and at least one third crease 166, which when foldedform two extensions 155 (FIG. 1 d) having upper and lower exposedsurfaces 182, 184. The extensions 155 may be foldable inward or outwardrelative to the perimeter of the body 142 of the container and theentire base transforms to a generally flat base for standing upright onits end. A pair of first creases 152 on each side of the base 144extends towards a centerline 162 of the container 140 at an angle fromthe tapered tail section 156 and outward towards a base corner 164 suchthat the pair of first creases meet at the base corner. In one exemplaryembodiment, the first creases 152 extend at about a 37 degree angle fromthe horizontal in the expanded position. The second crease 153, aroundwhich the extensions 155 are pivotable, extends along a border betweenthe tapered tail section 156 and the base 144 between each pair of firstcreases 152. The third crease 166 extends laterally along an end 168 ofthe container, substantially bisecting a thickness of the container.

To place the base 144 into a collapsed position from the expandedposition, a force is applied to the base in the direction of the port146, flattening the base and causing the extensions 155 to be defined bythe creases 115, 166. Accordingly, in a transition position between theexpanded position and the collapsed or folded position, as shown in FIG.3 d, the extensions 155 protrude from the tapered tail section 156, theextensions including a base 170 of a first dimension and taperingtowards a tip 172 of a second dimension. In one exemplary embodiment,the extensions 155 are substantially triangular. The extensions 155 canthen be folded along the second crease 153 towards the hanging tab 158to be tucked underneath the now flat base 144, as shown in FIG. 13 c. Inthis collapsed state, the extensions 155 serve as a support inconnection with the rest of the base 144 on which the container 140 canstand upright.

In one exemplar; embodiment, the container 140 is manufactured by theblow-fill-seal process described above. The mold is configured withridges so that when hot parison is blown against the mold, the creases145, 152, 153, 166 may be formed integral with the body 142 as thecontainer 140 is formed against the mold. Alternatively, some of thecreases may be created by the mold and some of the creases may becreated merely as a result of folding the extensions 155 between theexpanded state and the collapsed state.

With reference now to FIGS. 14 a-14 c, in another exemplary embodiment,a container 173 is shown incorporating a body 174 having a midsection175 and a tapered tail section 176 integral with a base 177 defined by abase crease 182. Similar to previously described embodiments, the base177 includes a plurality of first creases 178, a plurality of secondcreases 179, and a third crease 181, which when fold define twoextensions 183. More specifically, a pair of first creases 178 on eachside of the base 177 extends toward a centerline 162 of the body 174 atan angle from the tapered tail section 176 and outward toward a basecorner 1184 such that the pair of first creases meet at the base corner.The second crease 179, around which the extensions 183 are pivotable,extends along a border between the tapered tail section 176.Additionally, the body 174 includes a plurality of stress relief pointsor craters 180, each crater located between the base crease 182 and asecond crease 179. The craters 180 act as stress relief points thusallowing the extensions 183 to told outward, i.e., away from thecenterline 162, as opposed to toward the centerline when the base 177 istransformed from an expanded position to a folded position. Accordinglythe outwardly folded extensions 183 provide additional surface area andsupport for the base 177 on which the container 173 can stand upright.

In another exemplary embodiment, as shown in FIGS. 13 c and 14 c, thetapered tail sections 156, 176 may optionally include ribs 186 which addstructural integrity to the bases 144, 177, respectively and provideadditional support to allow the containers 142, 173 to stand thereon. Inone exemplary embodiment, the ribs 186 are formed by the same moldduring the blow-fill-seal process and are integral with the containers142, 173. Additionally, although three ribs are shown having asubstantially triangular shape, one of skill in the art will appreciatethat many different geometries and numbers of ribs may be incorporated.

With reference now to FIGS. 15 and 16, two schematic front views of twocontainers 200, 202 provided in accordance with aspects of the presentinvention are shown which preferably are blow-molded containers. Forpurposes of the following discussion, the container of FIG. 15 is a 50mL container while the container of FIG. 16 is a 250 mL container withdifferent volumetric sizes contemplated. The two containers eachincorporates a nozzle end 204 having a first nozzle 206, a second nozzle208 and a web 110 interconnecting the two. The web 210 optionallyincludes a passage or opening 212 for aesthetic appeal, for use inmanufacturing such as for hanging or registering, or both. In oneexemplary embodiment, the two nozzles 206, 208 of each container have apre-configured spacing measured between respective center axes of eachnozzle. More preferably, the spacing between each pair of nozzles ofeach container is generally the same even though their volumetricstorage capacities differ. Among other reasons making different sizedcontainers with a nozzle end having generally the same spacing betweentwo container nozzles allows for more efficient automation. As discussedabove, the two nozzles 206, 208 are configured to attach with upper portsections or terminal ports, such as with an additive port and a setport.

Also shown in FIGS. 15 and 16 are container body sections 214 and basesections 216. The body sections 214 of the different sized containersgenerally have the same width. The different volumetric capacities aretherefore due to differences in lengths. Alternatively, the containerscan be made to vary in widths to change their storage capacities. In oneembodiment, the base sections 216 of each container incorporate anintegrally formed hanging tab 218 having an opening 220. In oneembodiment, the hanging tab 218 is formed by compressing two mold-halvesagainst hot parison during a blow-fill-seal operation. The tabpreferably has a thickness in the order of 3/64^(th) inch to about⅛^(th) inch so that it resists canting over. This allows the tab toeasily be hung to a hook by a clinician or nurse without having toseparately hold the tab upright. Said differently, because the tab isformed from a thicker material, it will resist bending at the interfacewith the edge of the container to make hanging the container by the tabrelatively easier and without requiring a second hand to align the tabvertical for hanging on a hook.

With reference again to FIG. 16, the nozzle end 204 is formed on acontainer shoulder 222, which generally has a greater wall thicknessthan the wall thickness of the body section 214. The shoulder 222 can beviewed as having a generally planar section 224 and a skirt section 226,at the intersection between the generally planar section and the bodysection. Following molding and during the filling step, the shoulder 222will generally resist expansion due to its greater wall thickness, orexpand less, than the corresponding body and base sections. As furtherdiscussed below with reference to FIGS. 19-22, the nozzle end of thecontainer 214 defines a fixed end 228 not subject to post moldmanipulation. More preferably, the nozzle end 204 and the shoulder 222define a fixed end 228.

FIG. 17 is a perspective view of the container 200 of FIG. 15, oralternatively of the container 202 of FIG. 16. FIG. 18 is a side view ofthe container of FIG. 17. For purposes of the following discussions,reference is made only to container 202 of FIG. 16 although the sameapplies to container 200 of FIG. 15. As previously discussed, thecontainer is preferably made from a blow-fill-seal operation usingthermoplastic material, such as low density polyethylene (LDPE), highdensity polyethylene (HDPE), and polypropylene (PP) material with PPbeing more preferred and with LDPE being most preferred.

It has been found that as containers made by blow molding vary in size,their wall thicknesses are difficult to control or regulate. This isespecially true with smaller containers. Consequently, during use,containers may not collapse the same way even among containers ofsimilar sizes. Accordingly, an aspect of the present invention is acontainer and a method for making the container having pre-conditionedcollapsed state. Such pre-conditioned collapsed state facilitates thereturn of the container to that state. When it is drained of itscontents. With reference now to FIG. 19, a perspective view of thecontainer 202 of FIG. 17 is shown, which is clamped between two clamps230. In a particular embodiment, the clamps 230 are generally U-shapedand sized to only clamp along the perimeter of the container 200, 202,below the fixed end 228 and above the tab 218. Alternatively but lesspreferred, the clamps 230 may be solid and configured to clamp theentire body section 214 including the front and rear container wallsurfaces but excluding the fixed end 228. The clamps 230 are applied tothe container 202 immediately following the molding process but beforethe container is filled. In an embodiment, while the container has beenexpanded against the molds in the molding machine, but minimally cooledin the to-be-set areas, the container is removed and transferred to apressing station (not shown). The to-be-set areas of the container arepreferably warmer than the plastic material softening point. Morepreferably, with typical polypropylene co-polymers, the containerto-be-formed areas are is at about 270° F., such as greater than 250° F.but less than about 290° F. These targeted to-be-set areas of thecontainer may be preferentially maintained at a higher temperature thanthe other container areas by running hotter cooling water through themold zones corresponding to these to-be-set container areas. At thepressing station, the container 202 is held by its nozzle end 204, itstab 218 or both and tie two clamps are pressed together to compress thebody section of the container. The clamps are applied with justsufficient pressure to squeeze the plurality of edges of the container(i.e. the ‘to-be-formed’ areas) together but not overly applied so as topermanently deform the plurality of edges. The edges are held pressedtogether while they cool under said compression thereby re-forming intoa new permanently set compressed geometry. A cool gas stream, such asambient air, may blanket the container while it is being compressed toquench the container. Alternatively, the container may be allowed tocool to ambient temperature and then re-heated by a heat source, such asin an oven, by a radiant heat source, by direct contact with a heatedplates or by passing heated draft air or steam over and/or into thecontainer.

FIG. 20 is a side view of the assembly of FIG. 19. As clearly shown, theclamps 230 are preferably spaced from one another by a small gap toavoid structural damage to the container. In an embodiment spacers areprovided, such as dowels, pins or shoulders to ensure a minimal gapbetween the two clamps. In one exemplary embodiment, a gap of about3/64″ to 1/16″ of an inch is provided between two planar surfaces of thetwo clamps. The clamps may be separated after a few seconds, such asafter about 2 seconds to about 10 seconds, depending on the temperatureof the container when it was clamped and how effective the coolingprocess is (efficacy of the cool gas stream optionally applied). In anembodiment, the interior surface of the end section 232 of each clampmay be tapered to provide a smooth transaction with the arcuate fixedend 228 of the container. Alternatively, the clamps may be allowed toclose fully without spacers, limited solely by a limited and controlledapplied pressure.

FIG. 21 is a front view of the assembly of FIG. 19. The clamps 230 usedto compress the container may be made from a rigid metal material,alloy, or hard plastic, such as PEEK UHMWPE, polysulfone PTFE, etc.

FIG. 22 is a perspective view of the container 202 of FIG. 19 after theclamps 230 have been removed, i.e., after post mechanical treatment. Bytreating the container following the blow molding process, the containeris conditioned to collapse or return to its preferred flattened state,as shown, even after it has been inflated and subsequently drained, suchas by filling the container with a medicinal solution and dispensing thesolution. Thus, in accordance with aspects of the present invention,there is provided a container for storing fluid, said containercomprising a nozzle section comprising at least one nozzle, a bodysection, and a base section. The nozzle section comprises a shoulder,which has a width and a depth, orientated perpendicularly to oneanother. The depth of the shoulder has a larger dimension then the depthof the container body section measured between the front container walland the rear container wall, before the container is filled. In afurther aspect of the invention, the depth of the container body sectionmeasured between the front container wall and the rear container wall isabout the same or greater depth as the shoulder in a firstconfiguration, and wherein the depth is less than the depth of theshoulder in a second configuration. In a particular embodiment, thereduced depth of the body section from a first configuration to a secondconfiguration is caused by mechanical means, which in one embodimentincludes two clamps with opposing surfaces for squeezing the bodysection therebetween. In another embodiment, the post-blow-moldingtreatment is accomplished by a vacuum source, as discussed furtherbelow.

FIG. 23 is a side view of container of FIG. 22, showing the depth of theshoulder section 222 and the body section 214. As is clearly shown, thedepth of the shoulder section is greater than the depth of the bodysection due to the post-blow-molding treatment.

FIG. 24 is a schematic cross-sectional end view of a body section 214 ofthe container 202 of FIG. 16. The generally elliptical shape bodysection 214 of the container is the shape following the molding step,which represents the shape of the mold inserts of the blow moldingmachine. Although not shown, in one embodiment, the centerline edge orparting line 234 of the container is formed with a thickened or enlargedseam. This may be implemented by creating a small inset on the twomold-halves so that additional parison may flow into the inset spaceduring the blow molding process. The thickened centerline edge 234 ofthe container further facilitates the flattening process, as discussedabove.

As discussed above with reference to FIGS. 17-23, the container issubsequently processed in a pressing machine to flatten the bodysection. However, as the body section is pliable, the flattenedcontained may be filled with a fluid to return to its initially formedstate (FIG. 24) or even over-filled and expanded. FIG. 25 is a schematiccross-section end view of the body section 214 of a container, whichrepresents a condition in which the container is over-filled with afluid and is transformed to a more circular shape. Thus, for a fixedcontainer body surface, the transformation from a generally ellipticalshape to a more generally circular shape increases the volumetriccapacity of the container to thereby permit greater storage capacity.Accordingly, in an aspect of the present invention, there is provided acontainer comprising a first configuration comprising a generallyelliptical body section, a second configuration wherein the body sectionis flattened so that the body section has a width that is less than thewidth of a shoulder section, and a third configuration in which thedepth of the body section is greater than the depth at the firstconfiguration and second configuration. In a still yet further aspect ofthe present invention there is provided a method for post-blow-moldingmanipulation of a container comprising obtaining a blow molded containerhaving a first temperature greater than ambient temperature, applyingtwo clamping surfaces so that a body section of the container iscompressed by the two clamping surfaces and cooling the container to asecond temperature, which is less than the first temperature. Inspecific aspects of the present invention the two clamping surfaces areeach generally U-shaped and the container is clamped along its edges bythe U-shaped clamps.

Referring again to FIG. 22 in addition to FIG. 17, in one embodiment theblow molded container 202 (FIG. 17) is post blow mold treated bycoupling a vacuum source to one or both nozzles 206, 208 immediatelyfollowing the blow-molding process and while the container is stillwarm, as previously discussed. In one specific embodiment, the injectionpins used in the blow-molding process are coupled to a vacuum source.Thus, following the pressurization process to blow the hot parisonagainst the molds to form the container, the majority of the containersurface areas are allowed to cool in the mold, but the criticalto-be-formed areas are preferentially subject to minimal cooling, viaselectively warmed cooling zones in the mold areas. Immediately afterthe mold opens or alternatively the vacuum may be applied slightlybefore mold opening to speed the process, a vacuum is then pulled toevacuate air from the interior cavity of the container to flatten thecontainer. The flattened container resembles the container shown in FIG.22. During the vacuum process, additional draft air may be applied toquench or rapidly cool and ‘set’ the preferentially hotter areas of thecontainer. Once cooled, the container has a flattened shape in which thebody section is narrower than when originally formed by a blow-moldingprocess. Thus, an alternative method is herein provided to flatten ablow-molded container using a pneumatic source. Said container havingconditioned container edges to facilitate dispensing of fluid storedinside the container.

FIG. 26 is an enlarged perspective view of the nozzle section 204 of thecontainer 202 of FIG. 16, which also shows the shoulder 222, the twonozzles 206, 208, and the web 210 interconnecting the two. The twonozzles 206, 208 are each formed with generally cylindrical tubularsections 236 configured to receive an IV spike for administration or forreceiving a medical implement for adding fluids or other supplements.The tubular sections 236 each comprising a nominal outside diameter anda nominal inside diameter with certain draft angles formed from themolding process. A flange 238 is located at an end of each nozzle formating assembly with a corresponding flange of a set port or of anadditive port (See, e.g. FIG. 1). The mated flanges may be attached toone another using adhesive bonding. However, the attachment between theflanges is preferably by way of attachment welding as previouslydiscussed.

In one embodiment, a stepped structure 240 is located just distal of theflanges 238. In a preferred embodiment, the stepped structure 240comprises two ring-shaped steps 242. The stepped structure 240 may beformed by providing insets at corresponding nozzle sections of the moldsto create flowable space for excess hot parison to flow into duringinsertion of the blow pins during the blow molding process. It isdesirable that the necks of the ports have high quality fully filledconforming geometry referred to as a calibrated finish. To achieve thissufficient hot molten material from the parison must be pressed by theblow pines) and cutting rings into the mold cavity during blow pininsertion. Insufficient material insertion will result in voids, whileexcessive material will be pushed down into the throat of the ports bythe blow pin tips and potentially create irregular obstructions to theport-container inner generally tubular geometry. By providing a steppedring, incremental volumetric space is provided to accommodate variationsin the pushed-in excess material. In a most preferred embodiment, theinside diameter of the port over the first section, in practiceapproximately the first 5 mm, have a calibrated or sized finish tofacilitate an interference fit with the closing part applied postfilling to form a gas tight pre-seal prior to injection attachment.Therefore to achieve appropriate calibration, at least a slight excessof material should be available to fill the top port section and preventvoids. The stepped ring accommodates the needed excess material andprovides a space to accommodate the normal variability of quantity ofneeded excess material. In one embodiment, the formed stepped structure240 may also be utilized as a handling feature during containerfabrication by providing a ledge to be gripped by a robot arm or otherautomated devices. Accordingly, in an aspect of the present invention,there is provided a container comprising two nozzles spaced apart fromone another having an optional web disposed therebetween and connectedthereto. In one specific embodiment, a bridge having an enlarged rib islocated at the proximal end edge of the web and connects to two spacedapart ring-shaped steps. The ring-shaped steps each circumscribes anozzle and increases the outside diameter of the nozzle over a nominaloutside diameter. In a further aspect of the present invention, a methodis provided comprising obtaining the container having a steppedstructure and grabbing the stepped structure with an automation devicefor completing the container. An exemplary automation device includes arobotic arm or a pick-n-place arm.

FIG. 27 is a cross-sectional perspective view of the container 202 ofFIG. 17 taken along the parting line of the container between the frontside and the back side. Thus, FIG. 27 shows half of the nozzle section204, half of the body section 214, and half of the width or thickness ofthe tab section 218. Additionally, a set port 246 comprising a stopper248 is attached to the second nozzle 208 and an additive port 250comprising a septum 252 is attached to the first nozzle 206. Asdiscussed above with reference to the containers of FIGS. 1-9, thenozzle having the set port is configured to receive an IV spike 254while the nozzle having the additive port is configured to receive aneedle and the like for adding supplements or medicine to the contentsof the container. Additionally, the set port 246 may incorporate agroove or a bump as discussed above with reference to FIGS. 8 b and 9for use with a spike as discussed with reference to FIG. 8 a. Suchcombination has the benefit of providing tactile feedback to the userwhen the spike is appropriately inserted into the set port.

With reference now to FIG. 28 in addition to FIG. 27 an enlarged view ofthe set port 246, stopper 248, and second nozzle 208 is shown. Inpractice, the set port 246 includes a thermoplastic outer housing foraccommodating the stopper 248 as shown, for example shown in FIG. 2.Also shovel are pockets or expansion gaps 256, which in practice may bean annular space defined by a central section 262 and an outer peripheryof the stopper. The stopper 248 has a punctureable top surface 258 whilethe set port has a punctureable membrane 260, similar to the membranediscussed above with reference to other figures. As is well known in theart, when the IV spike 254 punctures the top surface 258 and themembrane layer 260, fluid is established between the contents of thecontainer and the patient connected to the far end of the IV line, whichis shown in FIG. 29. Also shown in FIG. 29 is the central section 262expanding radially outwardly to accommodate the spike 254. Consequently,the annular space 256 is reduced by the expanded central section 262when the spike is inserted. In certain instances, the annular space 256may disappear altogether if the ratio of the expanding central section262 is greater than the available expanded annular space. The lack ofspace for expansion is even greater as the size of the stopperdecreases, such as when used in connection with smaller sizedcontainers.

An additional issue with stoppers as they decrease in size is theability to adequately seal when the spike 254 is removed and the highdegree of force necessary to insert the spike. One contributing factorto these problems is the lack of material as stopper sizes decrease. Theresiliency of a stopper and its ability to rebound depend not only onthe type of rubber or elastomer used, but also on the thickness of thematerial at the point of expansion or compression. As such, smallersized stoppers are difficult to penetrate due to insufficient stoppermaterial, and therefore to adequately expand, and are less likely toseal.

With reference now to FIG. 30, a top view of an alternative stopperprovided in accordance with aspects of the present invention is shown,which is generally designated 264. In one embodiment, the stopper ismade from a thermoplastic elastomer (TPE) material. In a specificembodiment, the TPE is KRATON®, ethylene-propylene diene monomer (EPDM),SANOPRENE™, or PEBAX™ or alternatively from a thermoset elastomer, suchas polyisoprene. Although shown with different shading for purposes ofdiscussion, the preferred stopper 264 has a single uniform shading.

In one embodiment, the stopper 265 comprises a cylindrical outer wall266 and a plurality of ribs 268 in contact with and preferablysingularly formed with the outer wall 266. In one embodiment, sixspace-apart ribs are incorporated. However, two to five or more than sixribs may be incorporated without deviating from the spirit and scope ofthe present invention. A central penetrable section 270 is disposed atthe center of the stopper and in contact with the plurality of ribs 268,which in a preferred embodiment are singularly formed with the pluralityof ribs. The central penetrable section 270 has a top wall 271 but isotherwise hollow and has a cavity 276 (FIG. 32, which is a reversed viewof FIG. 30) defined by the central wall 278. A plurality of expansiongaps 272 are disposed in between the plurality of ribs 268 foraccommodating the central section 270, as further discussed below. Alsoshown at the bottom of the expansion gaps 272 is a base wall 274, whichis more clearly shown in FIG. 32. FIG. 31 is a perspective view of thestopper of FIG. 30, which more clearly shows the central wall 278.

With reference again to FIGS. 30-32, it is clear that certain sectionsof the stopper 264 are solid from outer wall to outer wall, shown forexample along lines 280, 282. However, other sections include voids orgaps for expansion, such as gaps 272. As such, when an IV spikepenetrates the top wall 271, the central wall 278 is configured toexpand into the gaps 272 while concurrently compress the ribs 268, whichreact thereto by bulging outwardly into the gaps 272. In reverse order,when the spike is removed from the central section 270, the solidsections 280, 282 of the stopper facilitates expansion of the centralsection 270 back to its original size to seal the void left by thespike. The sealing function may be further facilitated by housing thestopper inside a thermoplastic set port 246, which can further impart acompressive force on the stopper. This is readily seen by viewing thesolid sections returning to their original positions.

In one alternative embodiment, self-lubricating oil is incorporated intothe stopper to facilitate insertion of the spike through the centralsection 270. Exemplary self-lubricating oil is disclosed in Ser. No.11/942,163, entitled Needleless Access Port Valves, filed Nov. 19, 2007,the contents of which are expressly incorporated herein by reference.According to the '163 application, a two-part system designed for liquidinjection molding is available from Nusil Silicone Technology of SantaBarbara, Calif. Thus, an aspect of the present invention is themanufacturing of a stopper 264 using a mixture with self-lubricatingproperties. When A and B components are mixed together, which are soldby Nusil Silicone Technology in a two-part kit, in equal portions, theliquid will cure to a tough, rubbery elastomer via addition-curechemistry. After about sixty minutes of molding elapsed time, the curedsilicone rubber will begin to self-lubricate a silicone fluid fromwithin the wall surface of the piston to the piston exterior surfaces.The fluid flows from within the wall to the interior and exteriorsurfaces of the piston whenever the piston is stressed or squeezed, suchas when the piston is compressed and released within the valve housing.As the piston exudes lubricant to the surfaces, the mass or density ofthe piston reduces approximately an equal amount. The silicone oiltherefore provides lubricating properties to decrease friction as thespike penetrates the stopper, and as the spike is removed from thestopper.

Additionally, as bacteria growth is a concern, an additional aspect ofthe present invention is the inclusion of antimicrobial metals intoeither part A or part B prior to introducing the two streams into amixer to make the stopper. Exemplary antimicrobial metals includeprecious metals, such as silver, gold, platinum, copper, and zinc.Physiological antimicrobial metal compounds used herein include oxidesand salts of preferably silver and also gold. These agents includesilver acetate, silver benzoate, silver carbonate, silver citrate,silver chloride, silver iodide, silver nitrate, silver oxide, silversulfadiazine, silver sulfate, gold chloride and gold oxide. Platinumcompounds such as chloroplatinic acid or its salts (e.g., sodium andcalcium chloroplatinate) may also be used. Alternatively, oxides andsalts of copper and zinc such as those indicated above for silver mayalso be used. Preferred physiological antimicrobial metal compoundsusable with the preferred piston of the present invention include silveracetate, silver oxide, ionic silver, silver sulfate, gold chloride, anda combination of silver oxide and gold chloride. In one exemplaryembodiment, the agents are blended or mixed with stream A or stream Bprior to combining the two streams in the mixer of the injection moldingmachine. The amount of antimicrobial agents is preferably in the rangeof 2% to 8% by wt/wt ratio of the combined stream.

Printing of product information, labeling, trademark, etc. on thecontainers discussed elsewhere herein may be accomplished by using padprinting or hot stamping techniques. Hot stamping is a process in whichfoil is transferred to a substrate, such as the container surface, usingheat, pressure and length of time to press a heated die against thefoil, which is in contact with the substrate and which is supported by asolid surface, such as an anvil. In pad printing, a soft silicone pad isused and, because of its unique properties, is able to pick the image tobe printed from a flat plane and transfer it to a variety of surfaces,including flat, cylindrical, spherical, compound angles, textures,concave surfaces, and convex surfaces to name a few. In one embodiment,a filled container may be printed using pad printing. This may beaccomplished by laying the container onto a support surface andstretching the container so that it is taut. The support surface ispreferably arcuate so facilitate with the stretching. The silicone padis further supported by a rigid surface having a corresponding arcuatesurface. Pad printing and hot stamping techniques are well known in theart and further discussion is deemed unnecessary.

Although exemplary embodiments of the present invention have been shownand described, it will be appreciated by one of ordinary skill in theart that various modifications may be made without departing from thescope and spirit of the invention as defined in the claims below. Forexample, the exterior wall surfaces may include ridges for gripping orother aesthetic ridge/rib features, the sizes and shapes may be changed,and different materials may be used depending on the service and thecontents of the containers. Furthermore, features or structuresdiscussed for one container, such as having certain stoppers, creases,materials, nozzles, etc. may be used for other containers discussedelsewhere herein provided the features or structures are compatible.Accordingly, it is to be understood that the containers and theircomponents constructed according to principles of this invention may beembodied other than as specifically described herein. The invention isalso defined in the following claims.

1. A container comprising a body section, a base, and a nozzle sectioncomprising at least one nozzle attached to a terminal port comprising ahousing having a stopper positioned therein; said stopper comprising anouter wall defining a first central space, a central wall located insidethe first central space and connected to a top wall, a base wall joiningthe outer wall to the central wall, and a plurality of gaps between theouter wall and the central wall; said plurality of gaps defined by aplurality of spaced-apart ribs, each of said plurality of spaced-apartribs being in contact with both the outer wall and the central wall; andwherein at least two of the plurality of ribs are aligned evenly withthe top wall to form a continuous surface from one section of the outerwall to another section of the outer wall.
 2. The container of claim 1,wherein said terminal port is a set port comprising a punctureablemembrane located subjacent the base wall.
 3. The container of claim 1,further comprising a second nozzle spaced apart from the at least onenozzle and having a web therebetween.
 4. The container of claim 1,wherein the central wall defines a cavity sized to grip a spike.
 5. Thecontainer of claim 1, wherein the body section comprises at least threeedges having a front container wall surface and a rear container wallsurface extending therefrom.
 6. The container of claim 1, wherein thestopper is made from a self-lubricating silicone material.
 7. Thecontainer of claim 6, wherein the self-lubricating silicone material isimpregnated with antimicrobial metals.
 8. The container of claim 1,wherein the stopper comprises a material adapted for being pierced by asharp spike.
 9. A container comprising a body section, a base, and anozzle section comprising at least one nozzle comprising a puncturablemembrane attached to a terminal port comprising a housing having astopper positioned therein; said stopper comprising an outer wall, acentral section that is rupturable by an IV spike, a central wallconnected to the central section to define a central cavity, and a gapbetween the outer wall and the central wall; said gap being occupied bya plurality of spaced-apart ribs, each of said plurality of spaced-apartribs being in contact with both the outer wall and the central wall; andwherein a top wall is fixed axially relative to the ribs and the centralwall is expandable radially into the gap to accommodate an IV spike. 10.The container of claim 9, further comprising a second nozzle spacedapart from the at least one nozzle and having a web therebetween. 11.The container of claim 9, wherein the top wall punctured before thecentral wall can expand radially.
 12. The container of claim 9, whereinthe stopper is made from a self-lubricating silicone material.
 13. Thecontainer of claim 9, wherein a base wall connects the central wall tothe outer wall.
 14. The container of claim 12, wherein theself-lubricating silicone material is impregnated with antimicrobialmetals.
 15. The container of claim 9, wherein at least two of theplurality of spaced-apart ribs align with the top wall to define aplanar surface extending from one section of the outer wall to anothersection of the outer wall.